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Testing the Efficacy and Safety of the WEI Nasal Jet

NCT ID: NCT02005406

Last Updated: 2016-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

49 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-04-30

Brief Summary

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Testing the efficacy and safety of the WEI Nasal Jet.

Detailed Description

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This is only initial thought and suggestions from the inventor Dr. Huafeng Wei. Principal investigator from each medical center interested in testing this new device should design their own clinical trials based on patient population and their own ideas for clinical trials. Just remind you that patient safety is number one and try all efforts to minimize patient risks during your clinical study.

Conditions

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Complication of Surgical Procedure

Keywords

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Wei JET

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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wei group and control group

wei group(n=25) and control group(n=24)

Experimental group and control groupl

Intervention Type DEVICE

JET

Interventions

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Experimental group and control groupl

JET

Intervention Type DEVICE

Other Intervention Names

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WEI Control

Eligibility Criteria

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Inclusion Criteria

* Patients receiving various types of surgeries under sedation, especially for procedures of colonoscopy, upper gastrointestinal endoscopy, endoscopic retrograde cholangiopancreatography (ERCP) cystoscopy and other brief surgeries you are interested in the study.

Exclusion Criteria

* Patients with coagulopathy and tendency of nose bleeding.
* Patients with any diagnosed cardiac diseases (e.g. cardiac failure, angina, MI, cardiac arrhythmia. etc.)
* Patients with any diagnosed pulmonary disease (e.g. asthma, COPD, pulmonary embolism, pulmonary edema etc.)
* Pregnant patients
* Patients with liver failure
* Patients with kidney failure
Minimum Eligible Age

22 Years

Maximum Eligible Age

58 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Zeyong Yang

OTHER

Sponsor Role lead

Responsible Party

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Zeyong Yang

Shanghai Jiaotong University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zeyong Yang, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

References

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Yang ZY, Meng Q, Xu YH, Wang JW, Yu DS, Wei HF. Supraglottic jet oxygenation and ventilation during colonoscopy under monitored anesthesia care: a controlled randomized clinical trial. Eur Rev Med Pharmacol Sci. 2016;20(6):1168-73.

Reference Type DERIVED
PMID: 27049273 (View on PubMed)

Other Identifiers

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Wei JET

Identifier Type: -

Identifier Source: org_study_id